MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during a procedure, when attempting to withdraw the guide 0.18 mounted on the 21g puncture needle, the guide jammed, frayed, then broke off.The tip remained inside of the patient's anterior tibial artery.A request for more information and images was sent.
Additional Manufacturer Narrative
A review of the complaint history, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.The supplied mandril wire from the micropuncture transitionless pedal access set was returned in used, damaged condition.The wire guide was unraveled from the distal end of the proximal solder joint all of the way until the distal coil.The coil length could not be measured due to unraveling.The proximal solder joint looked fine with even flow, security, no holes, and rounded smooth.The length of the proximal solder connection was in compliance with specification.The distal solder joint at the tip of the wire could not be found.The length of the overall wire could not be measured due to the severe elongation and tangling of the coil.The length of the mandrel was in compliance with specification; however, the tip of the mandrel had a sheared appearance consistent with a cut performed by a sharp object.It was undetermined if a portion of the mandril was missing.The coil had been significantly stretched; therefore the coil length could not be measured.The diameter of the proximal solder connection and the diameter of the proximal core wire were outside of specification.However, it is unlikely that a proximal wire diameter smaller than the specification would cause a failure of the wire jamming, fraying (elongating), and breaking.The diameter of the coil was unable to be measured due to the elongation.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were two other reported complaints for this lot number.This type of device failure has generally been associated with the wire guide being damaged by withdrawal and/or manipulation through the needle.A warning label illustrates that wires should not be removed through a needle.The description of the event states that an attempt was made to remove the wire from the 21g needle; when the resistance was felt, then fraying was observed, breakage of the wire guide, and then the needle was removed.Therefore, a root cause of user technique is probable.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
It was reported that during a procedure on the anterior tibial distal artery, when attempting to withdraw the guide 0.18 mounted on the 21g puncture needle, the guide jammed, frayed, then broke off.The tip remained inside of the patient's anterior tibial artery.An attempt was made to recover the tip without success.No further information was provided.

• Brand Name: MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6093192
• Report Number: 1820334-2016-01237
• Device Sequence Number: 1694380
• Product Code: DYB
• UDI-Device Identifier: 00827002029729
• UDI-Public: (01)00827002029729(17)170826(10)5239035
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MPIS-401-PEDAL-NT-U-SST
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2016
• Supplement Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention